SITE002 (USA)

Sites / USA

SITE002 (USA)

USA · PI Dr. Nolan · activated

KRI 0.283

Patients

22

Active

22

Serious AEs

3

Open QA

2

Aged queries

1

Luna users

0

Studies & contracts

1

A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer

Phase III · study active · 330000 USD

executed

Patients

22

SITE002-0018

enrolled

SITE002-0025

enrolled

SITE002-0054

enrolled

SITE002-0062

enrolled

SITE002-0069

enrolled

SITE002-0071

enrolled

SITE002-0132

enrolled

SITE002-0153

enrolled

SITE002-0171

enrolled

SITE002-0180

enrolled

SITE002-0187

enrolled

SITE002-0188

enrolled

SITE002-0193

enrolled

SITE002-0202

enrolled

SITE002-0209

enrolled

SITE002-0214

enrolled

SITE002-0235

enrolled

SITE002-0237

enrolled

SITE002-0241

enrolled

SITE002-0244

enrolled

SITE002-0270

enrolled

SITE002-0295

enrolled

Safety

64 AEs · 3 serious

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 65); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE002-0171

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-07-27 (study day 119); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE002-0025

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-22 (study day 30); relationship: not assessed; serious criteria: life-threatening

serious SITE002-0062

QA findings

2 open

Audit observation: two informed consent forms signed by the participant but missing the investigator countersignature date (ICH E6(R3) 2.8).

open major

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE002-0025, 2026-08-25)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE002-0237, 2026-08-15)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE002-0214, 2026-08-13)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE002-0241, 2026-07-15)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE002-0202, 2026-06-15)

resolved minor

LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE002-0071, 2026-05-29)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE002-0062, 2026-04-16)

resolved minor

OTHER: Informed consent form not signed prior to randomisation (subject SITE002-0062, 2026-03-21)

open major

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE002-0071, 2026-02-09)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE002-0054, 2026-01-17)

resolved minor

Visits & payments

0

Nothing scheduled. Re-score risk to let the pipeline propose a visit.

Luna participants

0

No Luna participants here yet. Participants join once invited by the site.

Open Luna